MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-6 patient race: unknown/asked information was not provided.Section h-3 device evaluated by manufacturer: the device was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The pre-loaded diu150 model intraocular lens (iol) was reported to have been implanted in the patient's eye.The iol was explanted and replaced with a dib00 23.0 diopter iol that was implanted in the patient¿s ocular dexter (right eye).Patient visual acuity post-lens exchange was reported as 20/40.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information/corrected data: although, it was initially indicated that the lens was discarded and is not available for return; however, additional information received indicated that the lens is available for return.In review, it was also noticed that an incorrect implant date of ((b)(6) 2024) for "d6a" was inadvertently entered in section "h11" of the initial mdr report; therefore, the following field were updated accordingly: section d6a: if implanted; give date: (b)(6) 2024.The following code is no longer applicable to this event: section h6: type of investigation: 4115 - device discarded.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: apr 3, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the lens was cut into three pieces and stuck to a piece of medical tape.The lens was removed from the tape and observed to be coated in viscoelastic residue and tape residue.The lens was cleaned and inspected and no further issues were identified.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20873482
• Report Number: 3012236936-2024-000327
• Device Sequence Number: 8831815
• Product Code: MJP
• UDI-Device Identifier: 05050474746657
• UDI-Public: (01)05050474746657(17)270809
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 12/07/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Hispanic